Humidity-indicating medical sample system and method

• US 5,520,041 A
• Filed: 04/18/1994
• Issued: 05/28/1996
• Est. Priority Date: 04/18/1994
• Status: Expired due to Fees

• Current Assignee: Hooper Kit Services LLC (Village Practice Management Co. LLC)
• Original Assignee: Beckwell International, Inc.
• Inventors: Haswell, James S.
• Primary Examiner(s): Williams, Hezron E.
• Assistant Examiner(s): WIGGINS, JOHN DAVID
• Application Number:
  US08/229,022
• Time in Patent Office: 771 Days
• Field of Search: 73/29.04, 73/24.04, 73/31.01, 73/73, 436/808, 435/805, 422/55, 422/56, 422/57, 422/58, 422/61, 422/86
• US Class Current: 73/29.04
• CPC Class Codes: G01N 31/222 for investigating moisture content
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 436/808 Automated or kit

Abstract

A medical specimen collection system includes a blood specimen collection subsystem including a blood specimen card. The blood specimen card comprises a blotter-type absorbent material with locations for receiving blood droplets. A humidity-indicating pouch comprising, for example, a cobalt chloride composition applied to blotter-type absorbent substrate is mounted on the blood specimen card in fluidic communication therewith. The humidity-indicating patch changes color in response to changing moisture levels. The blood specimen card must have less than a predetermined moisture content for processing of the samples thereon. The system can comprise a prepackaged kit which also includes a urine specimen collection subsystem and a labeling/mailing subsystem with adhesive labels and a mailing envelope. A medical specimen collection method includes the steps of obtaining blood and urine specimens, indicating a moisture content of a blood specimen card, drying the blood specimen card if necessary and mailing the collective specimens.

Claims

1. A humidity-indicating medical sample card which includes:

(a) medical specimen receiving means disposed on an area of said sample card; and

(b) humidity-indicating means mounted on said card in spaced relation apart from the area of said medical sample receiving means.

2. The card of claim 1, which includes:

(a) a plurality of printed medical sample receiving areas.

3. The card of claim 1, which includes:

(a) said humidity indicating means comprising a patch adhesively mounted on said card.

4. The card for receiving medical specimens of claim 3 wherein said humidity indicating means includes color-changing means for changing colors responsive to humidity levels on said card, said color-changing means for indicating moisture content on and in said sample cared being reversibly and alterably responsive to changing moisture contents of air at the humidity indicating patch means on said card at a second area.

5. The card of claim 4 wherein said color-changing means comprises a patch of blotting paper impregnated with cobalt chloride.

6. The card of claim 1, which comprises cotton fiber blotting material.

7. A medical sample handling system for collecting, transporting and monitoring a medical sample, which includes:

(a) a medical sample card having front and back faces, a sample area on said front face for receiving a medical specimen disposed at a first location thereon, and a humidity indicator area on said front face disposed at a second location thereon for indicating the moisture content on and in the medical sample card;

(b) a humidity-indicating patch including means for changing color in response to changing humidity levels, said patch being mounted on said humidity indicator area of said card;

(c) an envelope including a pocket for receiving said card; and

(d) desiccant means receivable in said envelope pocket with said card.

8. (claim 8 rewritten in independent form) A medical sample handling system for collecting, transporting and monitoring a medical sample, which includes:

(a) a medical sample card having front and back faces, a sample area on said front face for receiving a medical specimen, and a humidity indicator area on said front face for indicating moisture content on and in said sample card;

(b) a humidity-indicating patch including means for changing color in response to changing humidity levels, said patch being mounted on said humidity indicator area of said card;

(c) an envelope including a pocket for receiving said card;

(d) desiccant means receivable in said envelope pocket with said card;

(e) said sample card being a blood sample card; and

(f) urine specimen collection means also insertable into said envelope.

9. (claim 9 rewritten in independent form) A medical sample handling system for collecting, transporting and monitoring a medical sample, which includes:

(a) a medical sample card having front and back faces, a sample area on said front face for receiving a medical specimen, and a humidity indicator area disposed at a second area on said front face for indicating moisture content on and in said sample card;

(b) a humidity-indicating patch including means for changing color in response to changing humidity levels, said patch being mounted on said humidity indicator area of said card;

(c) an envelope including a pocket for receiving said card;

(d) desiccant means receivable in said envelope pocket with said card;

(e) said envelope pocket comprising a sample card pocket; and

(f) said envelope also having a urine specimen pocket for receiving said urine specimen collection means.

10. (claim 10 rewritten in independent form) A medical sample handling system for collecting, transporting and monitoring a medical sample, which includes:

(a) a medical sample card having front and back faces, a sample area on said front face for receiving a medical specimen, and a humidity indicator area disposed at a second area on said front face for indicating moisture content on and in said sample card;

(b) a humidity-indicating patch including means for changing color in response to changing humidity levels, said patch being mounted on said humidity indicator area of said card;

(c) an envelope including a pocket for receiving said card;

(d) desiccant means receivable in said envelope pocket with said card; and

(e) said sample card pocket being lined with a substantially fluid-impervious layer.

14. A medical sample handling system for collecting, transporting and monitoring blood and urine specimens from a subject, which comprises:

(a) a blood specimen collection subsystem including;

(1) a blood sample card comprising blotter paper and having front and back faces, upper and lower portions, upper and lower edges adjacent to the upper and lower portions respectively, and opposite side edges;

(2) a card fold line extending across said card substantially midway between said side edges, said card fold line extending between said card upper and lower edges;

(3) a plurality of blood-droplet receiving circles printed on said card front face upper portion;

(4) a barcode label area on said card front face lower portion;

(5) a humidity-indicating patch including means for changing color in response to changing humidity levels, said patch being mounted on said card front face lower portion in fluidic communication with said card;

(6) said card having a flat, mailing configuration and a drying configuration folded along said fold line and resting on card side edges;

(7) a lancet; and

(8) bandage means;

(b) a urine specimen collection subsystem, which includes a urine collection vial with a removable, substantially fluid-tight lid; and

(c) a labeling/mailing subsystem, which includes;

(1) an envelope having front and back panels, top and bottom edges, first and second side edges and a closure flap, said envelope front and back panels being connected along said upper and lower edges, along one of said side edges and along a medial strip extending in generally parallel, spaced relation between said top and bottom edges;

(2) said envelope having upper and lower pockets separated by said medial strip;

(3) an adhesive strip on said closure flap;

(4) a substantially fluid-impervious liner lining said upper and lower pockets;

(5) a test and subject information form including a preprinted barcode indicia, a blood specimen card label with barcode indicia matching the barcode indicia preprinted on said form, a urine vial label mounted on said forming and including barcode indicia matching the barcode indicia preprinted on said form;

(6) a tamper-evident tape strip for placement over said urine vial cover sealing same on said urine vial;

(7) a desiccant packet receivable in said upper envelope pocket with said blood specimen card;

(8) a fluid-absorbent pouch adapted for receiving said urine collection vial and receivable in said envelope lower pocket; and

(9) preprinted return address means on said envelope front panel.

15. A medical sampling method, which includes the steps of:

(a) providing a blood sample collection card for receiving one or more blood droplets;

(b) providing a humidity-indicating patch for indicating the moisture content on and in said collection card;

(c) mounting said humidity-indicating patch at a specified location on said blood sample collection card;

(d) placing a subject'"'"'s blood droplet on said blood sample collection card at an area different from the specified location of said humidity-indicating patch; and

(e) drying said blood droplet while monitoring the color of said humidity-indicating patch.

11. (claim 16 rewritten in independent form) A medical sampling method, which includes the steps of:

(a) providing a blood sample collection card for receiving one or more blood droplets;

(b) providing a humidity-indicating patch at a specified location on blood sample collection card for indicating moisture content on and in said blood sample collection card;

(c) mounting said humidity-indicating patch on said blood sample collection card;

(d) placing a subject'"'"'s blood droplet on said blood sample collection card at an area different from the specified location of said humidity-indicating patch;

(e) drying said blood droplet while monitoring the color of said humidity-indicating patch;

(f) providing a return mailing envelope with a blood specimen card pocket;

(g) placing said blood sample card in said envelope pocket;

(h) mailing said envelope containing said blood sample card;

(i) providing a urine vial;

(j) obtaining a urine specimen;

(k) sealing said urine specimen in said urine vial;

(l) providing a urine vial pocket in said envelope; and

(m) sealing said urine vial in said urine vial pocket.

12. (claim 17 rewritten in independent form) A medical sampling method, which includes the steps of:

(a) providing a blood sample collection card for receiving one or more blood droplets;

(b) providing a humidity-indicating patch at a specified location on blood sample collection card for indicating moisture content on and in said blood sample collection card;

(c) mounting said humidity-indicating patch on said blood sample collection card;

(d) placing a subject'"'"'s blood droplet on said blood sample collection card at an area different from the specified location of said humidity-indicating patch;

(e) drying said blood droplet while monitoring the color of said humidity-indicating patch;

(f) providing a fold line extending across said blood sample collection card;

(g) folding said blood sample collection card to a drying configuration; and

(h) drying said blood sample collection card.

13. (claim 18 rewritten in independent form) A medical sampling method, which includes the steps of:

(a) providing a blood sample collection card for receiving one or more blood droplets;

(b) providing a humidity-indicating patch at a specified location on blood sample collection card for indicating moisture content on and in said blood sample collection card;

(c) mounting said humidity-indicating patch on said blood sample collection card;

(d) placing a subject'"'"'s blood droplet on said blood sample collection card at an area different from the specified location of said humidity-indicating patch;

(e) drying said blood droplet while monitoring the color of said humidity-indicating patch;

(f) providing a test and subject identification form;

(g) preprinting said identification form with barcode indicia;

(h) providing a blood sample collection card label with barcode indicia matching said preprinted barcode indicia printed thereon; and

(i) applying said blood sample collection card label to said blood sample collection card.

16. The method of claim 15, which includes the additional steps of:

(a) providing a return mailing envelope with a blood specimen card pocket;

(b) placing said blood sample card in said envelope pocket; and

(c) mailing said envelope containing said blood sample card.

17. The method of claim 16, which includes the additional steps of:

(a) providing a desiccant packet; and

(b) placing said desiccant packet in said envelope pocket.

18. The method of claim 16, which includes the additional steps of:

(a) providing a urine vial;

(b) obtaining a urine specimen;

(c) sealing said urine specimen in said urine vial;

(d) providing a urine vial pocket in said envelope; and

(e) sealing said urine vial in said urine vial pocket.

19. The method of claim 15, which includes the additional steps of:

(a) providing a fold line extending across said blood sample collection card;

(b) folding said blood sample collection card to a drying configuration; and

(c) drying said blood sample collection card.

20. The method of claim 15, which includes the additional steps of:

(a) providing a test and subject identification form;

(b) preprinting said identification form with barcode indicia;

(c) providing a blood sample collection card label with barcode indicia matching said preprinted barcode indicia printed thereon; and

(d) applying said blood sample collection card label to said blood sample collection card.

21. The method of claim 15, which includes the additional steps of:

(a) providing a lancet; and

(b) piercing a subject'"'"'s finger with said lancet to obtain blood droplets therefrom.

22. The method of claim 15, which includes the additional step of:

(a) placing multiple blood droplets on said blood sample collection card.